BINAX NOW COVID-19 AG CARD KIT 40T EUA
Report
- Report Number
- 1221359-2023-00305
- Event Type
- Malfunction
- Date Received
- February 14, 2023
- Date of Event
- February 1, 2023
- Report Date
- April 28, 2023
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QKP
- UDI-DI
- 10811877011290
- PMA / PMN Number
- EUA202537
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 501
Narratives
THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE, DEVICE DISCARDED.
THE REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, A REVIEW OF COMPLAINTS' TREND REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO THE STATEMENTS MADE IN THE PACKAGE INSERT. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.
B3 (DATE OF EVENT): THIS IS AN ESTIMATED DATE AS THE CUSTOMER REPORTED AN ADDITIONAL UNKNOWN QUANTITY WITHOUT SPECIFYING THE DATES. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.B1, B5, D4 (LOT NUMBER, EXPIRATION DATE), H4, H6 (HEALTH EFFECT - IMPACT CODE) H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED
THE CUSTOMER REPORTED 5 (FIVE) FALSE NEGATIVES WITH THE BINAXNOW COVID-19 ANTIGEN CARD EXTENDED EXPIRATION DATE PERFORMED ON MULTIPLE DAYS. THIS MFR. REPORT ADDRESSES TEST 3 (THREE) OF 5 (FIVE). ON (B)(6) 2023, 4 (FOUR) PATIENTS WERE TESTED NEGATIVE WITH BINAXNOW COVID-19 ANTIGEN CARD LOT 193255. A DIFFERENT BINAXNOW COVID-19 ANTIGEN CARD LOT (UNKNOWN) WAS USED AND GENERATED POSITIVE RESULTS. THE CUSTOMER STATED THAT THE PATIENT WAS UNABLE TO RECEIVE COVID-19 SPECIFIC TREATMENT DUE TO THE NEGATIVE TEST RESULT. HOWEVER, THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN CARD FOR MULTIPLE PATIENTS, LOT NUMBERS, AND TESTS PERFORMED ON UNKNOWN DATES. CONFIRMATION TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CUSTOMER REPORTED THAT THE PATIENT WAS UNABLE TO RECEIVE COVID-19 MEDICATION DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER REPORTED THE RESULTS MAY HAVE "POTENTIALLY CONTRIBUTED TO THE FURTHER SPREAD OF COVID AND POSSIBLE DELAY OF TREATMENT" FOR OTHERS. NO ADDITIONAL INFORMATION WAS PROVIDED.
THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN CARD FOR MULTIPLE PATIENTS, LOT NUMBERS, AND TESTS PERFORMED ON UNKNOWN DATES. CONFIRMATION TESTING WAS NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CUSTOMER REPORTED THAT THE PATIENT WAS UNABLE TO RECEIVE COVID-19 MEDICATION DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER REPORTED THE RESULTS MAY HAVE "POTENTIALLY CONTRIBUTED TO THE FURTHER SPREAD OF COVID AND POSSIBLE DELAY OF TREATMENT" FOR OTHERS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 964252 | BINAX NOW COVID-19 AG CARD KIT 40T EUA | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 193255 | 10811877011290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |